Assessment of NIR spectroscopy for nondestructive analysis of physical and chemical attributes of sulfamethazine bolus dosage forms

AAPS PharmSciTech

Volumn 6, Issue 1, 2005, Pages

  Tatavarti, Aditya S ^a   Fahmy, Raafat ^b   Wu, Huiquan ^b   Hussain, Ajaz S ^b   Marnane, William ^b   Bensley, Dennis ^b   Hollenbeck, Gary ^a   Hoag, Stephen W ^a  

^a UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Cornstarch paste granulation; Near infrared (NIR); Partial least squares (PLS); Principal component analysis (PCA); Sulfamethazine

Indexed keywords

BORIC ACID; MAGNESIUM STEARATE; STARCH; SULFADIMIDINE;

ANALYTICAL ERROR; ARTICLE; CALIBRATION; CHEMICAL PARAMETERS; CONTROLLED STUDY; CORRELATION ANALYSIS; CORRELATION COEFFICIENT; DRUG DETERMINATION; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG GRANULATION; DRUG SOLUBILITY; LINEAR REGRESSION ANALYSIS; NEAR INFRARED SPECTROSCOPY; PHYSICAL PARAMETERS; PLOTS AND CURVES; PREDICTION; PRINCIPAL COMPONENT ANALYSIS; REFLECTOMETRY; REGRESSION ANALYSIS; TABLET COMPRESSION; TABLET HARDNESS; VALIDATION PROCESS; WATER CONTENT;

COMPRESSIVE STRENGTH; DOSAGE FORMS; REPRODUCIBILITY OF RESULTS; SOLUBILITY; SPECTROSCOPY, NEAR-INFRARED; SULFAMETHAZINE;

EID: 27744599367     PISSN: 15309932     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/pt060115     Document Type: Article

References (22)

1. Ritchie GE, Roller RW, Ciurczak EW, Mark H, Tso C, MacDonald SA. Validation of a near-infrared transmission spectroscopic procedure Part B: Application to alternate content uniformity and release assay methods for pharmaceutical solid dosage forms. J Pharm Biomed Anal. 2002;29:159-171.
2. Candolfi A, De Maesschalck R, Massart DL, Hatilcy PA, Harrington AC. Identification of pharmaceutical excipients using NIR spectroscopy and SIMCA. J Pharm Biomed Anal. 1999;19:923-935.
3. Ulmschneider M, Pénigault E. Direct identification of key intermediates in containers using Fourier-transform near-infrared spectroscopy through the protective polyethylene primary packaging. Analysis. 2000;28:136-140.
4. Otsuka M, Katol F, Matsuda Y, Ozaki Y. Comparative determination of polymorphs of indornethacin in powders and tablets by chemometrical near-infrared spectroscopy and X-ray powder diffractometry. AAPS PharmSciTech. 2003;4:E19.
5. Buckton G, Yonernochi E, Yoon WL, Moffat AC. Water sorption and near IR spectroscopy to study the differences between microcrystalline cellulose and silicified microcrystalline cellulose before and after wet granulation. Int J Pharm. 1999;181:41-47.
6. Rantanen J, Rasanen E, Tenhunen J, Kansakoski M, Mannennaa J, Yliruusi J. In-line moisture measurement during granulation with a four-wavelength near infrared sensor: evaluation of particle size and binder effects. Eur J Pharm Biopharm. 2000;50:271-276.
7. Lodder RA, Selby M, Hieftje GM. Detection of capsule tampering by near-infrared reflectance analysis. Anal Chem. 1987;59:1921-1930.
8. Derbyshire HM, Feldman Y, Bland CR. Broadhead J, Smith G. A study of the molecular properties of water in hydrated mannitol. J Pharm Sci. 2002;91:1080-1088.
9. Drennen JK, Lodder RA. Nondestructive near-infrared analysis of intact tablets for determination of degradation products. J Pham Sci. 1990;79:622-627.
10. Gustafsson C, Nystroem C, Lennholm H, Bonferoni MC, Caramella CM. Characteristics of hydroxypropyl mcthylcellulose influencing compactibility and prediction of particle and tablet properties by infrared spectroscopy. J Pharin Sci. 2003;92:494-504.
11. Kuny T, Schatz C, Ulmschneidcr M, Marrer S, Leuenberger H. Non-destructive dissolution testing correlation. Dissolution Technologies. 2003;10:22-28.
12. Morisseau KM, Rhodes CT. Near-infrarcd spectroscopy as a nondestructive alternative to conventional tablet hardness testing. Pharm Res. 1997;14:108-111.
13. Reich G. Potential of attenuated total reflection infrared and near-infrared spectroscopic imaging for quality assurance/quality control of solid pharmaceutical dosage forms. Pharm Ind. 2002;64:870-874.
14. Otsuka M, Mouri Y, Matsuda Y. Chemometric evaluation of pharmaceutical properties of antipyrine granulates by near-infrared spectroscopy. AAPS PharmSciTech. 2003;4: E47.
15. Higgins JP, Arrivo SM, Thurau G, et al. Spectroscopic approach for on-line monitoring of particle size during the processing of pharmaceutical nanoparticles. Anal Chem. 2003;75:1777-1785.
16. Fahmy R, Marnane W, Bensley D, Hollenbeck G. Dissolution testing of veterinary products. Dissolution Technologies. 2001;8:8-14.
17. Du J, Hoag SW. Characterization of excipient and tableting factors that influence folic acid dissolution, friability and breaking strength of oil- and water-soluble multivitamin with minerals tablets. Drug Dev Ind Pharm. 2003;29:1137-1147.
18. Kramer R. Chemometric Techniques for Quantitative Analysis. New York, NY: Marcel Dekker Inc; 1998.
19. Brereton RG. Chemomctrics Data Analysis for the Laboratory and Chemical Plant. Chichester, UK: John Wiley & Sons Ltd; 2003.
20. Otto M. Chemometrics Statistics and Computer Application in Analytical Chemistry. Weinheim, Germany: Wiley-VCH; 1999.
21. Wu H, Lyon RC, Hussain AS, et al. Application of principal component analysis in assessing pharmaceutical formulation design: exploring the causal links between the tablet processing conditions and drug dissolution rate. AICHE Topical Conference: Discovery, Development, and Delivery of Medicines. AICHE Annual Meeting; November: 17-19, 2003: San Francisco, CA: 635-642.
22. Beebe KR, Pell RJ, Seasholtz MB. Chemometrics: A Practical Guide. New York, NY: John Wiley & Sons Inc; 1998.